Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules (NCT06381557) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Cancer-related Fatigue in Patients With Breast Cancer Treatment With Zhengyuan Capsules
240 participantsStarted 2024-05-01
Plain-language summary
Traditional Chinese medicine（TCM） has achieved some meaningful results in improving the symptoms and quality of life of cancer patients, but many research results need to be further verified by clinical trials with larger samples and better design.This study aims to investigate effectiveness and safety of Zhengyuan Capsules for cancer-related fatigue in patients with breast cancer.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histopathologically or cytologically confirmed as breast cancer; AJCC 8th edition staging for breast cancer is stages I to III, clinically and radiologically confirmed with no tumor recurrence or metastasis.
. Completed anti-tumor treatment (surgery, radiotherapy, chemotherapy, targeted therapy) for at least 2 months, with no planned anti-tumor treatment during the study period, excluding endocrine therapy.
. Meets the diagnosis criteria for cancer-related fatigue.
. Average score on the Brief Fatigue Inventory (BFI) in the 14 days preceding enrollment is ≥4.
. Life expectancy of at least 6 months.
. Age between 18 and 70 years old.
. Patients and their families understand the basic details of the study, agree to cooperate in completing the relevant research; the patient can communicate verbally and in writing; voluntary signing of the informed consent form.
Exclusion criteria
. Presence of significant liver or kidney dysfunction (e.g., alanine transaminase, aspartate transaminase greater than 3 times the upper limit of normal, blood creatinine greater than 1.5 times the upper limit of normal, eGFR \<60 mL/min/1.73m²) or abnormalities in the hematological system (platelet count \<75×10⁹/L, hemoglobin \<100g/L, or neutrophil count \<1.5×10⁹/L);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Fatigue degree with the Brief Fatigue Inventory（BFI）
. Presence of severe primary diseases in the cardiovascular, cerebrovascular, immune systems, or requiring treatment for mental illness;
. Hypokalemia (blood potassium \<3.0mmol/L) or electrolyte imbalance with related symptoms or symptoms that may occur after enrollment;
. Unimproved hypothyroidism;
. Hypoalbuminemia (blood albumin \<30g/L) or malnutrition (Body Mass Index, BMI \<18 kg/m²);
. Traditional Chinese medicine syndrome pattern consistent with Yin deficiency and internal heat;
. Use of medications indicated in the instructions or with main functions that meet the following conditions: other Western or Chinese medicine preparations that affect the efficacy evaluation of cancer-related fatigue; undergoing treatment with anti-anemia, anti-anxiety/depression, anti-insomnia, or other psychostimulant drugs; use of drugs with leukocyte-increasing effects within the past week, such as granulocyte colony-stimulating factor (G-CSF);
. Known allergy to the investigational drug or its components;